Maastricht Department of Psychopharmacology tests new sleeping pill
The Department of Psychopharmacology at Maastricht University once again received a major commission from a drug manufacturer, this time the Japanese company Eisai, to test the effects of a sleeping drug on driving ability. This clinical trial is required by the American Food and Drug Administration (FDA) before the drug can be marketed. Thanks to twenty-eight years of experience with this type of research, which includes supervising test subjects while they drive, the Maastricht research group more than meets the strict requirements set by the FDA. Half of the test subjects for this new study must be 65 years old or older, as this constitutes the largest target group for the new sleeping pill.
Traditional sleeping pills fall under the benzodiazepine class of drugs, which stimulate the neurotransmitters in the brain involved in muscle relaxation and sleepiness, among other things. This new drug works very differently: it inhibits the neurotransmitter responsible for excitement and wakefulness. This so-called ‘orexin antagonist’ is expected to have far fewer residual effects the morning after ingestion. The research question therefore focuses on whether drug levels will drop sufficiently enough to allow the user to safely operate a car the morning after.
Forty-eight volunteers
Forty-eight volunteers will each be given a sleeping pill before bed for seven consecutive nights. Some will receive the new sleeping pill in two different doses, some will receive a placebo and some will receive a popular and well-known sleeping pill. After the first night and the seventh night, which is spent in a Maastricht hotel under the supervision of a doctor, they will drive for one hour on the freeway, accompanied by a driving instructor in a special test car. Their driving ability will be measured with particular attention to ‘swerving’, a scientifically proven indicator of sleepiness.
Strict requirements
These clinical trials are subject to extremely high requirements, down to the smallest detail. ‘Our group has acquired vast experience over the course of more than twenty-eight years and we’re incredibly proud that we meet the strict requirements of the FDA,’ says research leader Eric Vuurman. Ultimately, the drug will predominantly be used by older people, which is why this group is being expressly studied. Half of the volunteers will be between 21 and 64 years old and the other half will be 65 or older. The entire study is expected to take approximately eighteen months.
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